510(k) K854049

HEYER-SCHULTE SYRINGO PERITONEAL SHUNT by American V. Mueller — Product Code JXG

K854049 is an FDA 510(k) premarket notification submitted by American V. Mueller for the device "HEYER-SCHULTE SYRINGO PERITONEAL SHUNT". The FDA issued a decision of Substantially Equivalent on November 27, 1985. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. American V. Mueller has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1985
Date Received
October 3, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type